Healthcare Industry News: tumor localization
News Release - April 27, 2011
Gamma Medica and Mayo Clinic Publish Preliminary Results of Low Dose Molecular Breast Imaging Screening Study for Women with Dense Breasts
Results point to low-dose MBI as a useful adjunct and potential alternative to screening mammography in women with dense breastsNORTHRIDGE, Calif.--(Healthcare Sales & Marketing Network)-- Published in the April issue of Journal of Nuclear Medicine, Gamma Medica, Inc. and Mayo Clinic of Rochester, MN release the much anticipated preliminary results of a Low Dose Molecular Breast Imaging (MBI) Screening Study in Women with Dense Breasts.
The LumaGEM™ Molecular Breast Imaging (MBI) System, by Gamma Medica, has been clinically proven to be an effective secondary diagnostic screening tool for breast imaging in women with mammographically dense breasts (see recently published clinical study in the Jan. 2011 issue of Radiology (doi:10.1148/radiol.10100625) whereby MBI effectively demonstrated superior sensitivity (91% when combined with mammography) and specificity (93%) results over mammography in 1,000 patients.
The Radiology published study was a proof-of-principle study, performed with 740 MBq (20 mCi) Tc-99m Sestamibi, the radiopharmaceutical probe used for tumor localization and imaging. With recent implementations of dose reduction methods for MBI, including optimized collimation and energy acceptance window, a new Mayo Clinic study, funded by the Susan G. Komen Foundation, is currently underway with the objective to compare performance of incident screen mammography and prevalent screen low-dose MBI in 2,400 women with dense breasts.
The following are the highly anticipated preliminary results of this study, which are currently published in the April, 2011 issue of Journal Nuclear Medicine.
STUDY METHODS: Women presenting for screening digital mammography between June 2010 and January 2011 who had heterogeneously dense or extremely dense breasts on prior mammograms were enrolled. All participants underwent both a mammogram and Molecular Breast Imaging (MBI) scan. MBI was performed with 296 MBq (8mCi) injection of Tc-99m Sestamibi and dual head CZT detectors and acquired in dynamic frames to allow generation of 148 MBq (4 mCi) equivalent images. Mammograms and MBI’s were read independently by 2 different radiologists. MBI’s were assigned an assessment score of 1-5 which parallel BI-RADS’s; scores of 3-5 on MBI were considered positive and led to diagnostic workup.
PRELIMINARY RESULTS: In 440 women studied to date, 6 cancers were diagnosed in 6 patients. MBI detected cancer in 5 of 6 patients (83%) and Mammography detected none. The remaining cancer was detected on prophylactic mastectomy (7 mm invasive lobular carcinoma). Mammographically occult cancers detected by MBI included 2 cases of DCIS (6 and 15 mm), tubular cancer (7mm) and invasive lobular carcinoma (36mm). A total of 79 women were recalled for diagnostic evaluation of findings; 35 due to prevalent MBI alone, 40 due to incident mammogram alone, and 4 due to both tests. Eighteen women underwent biopsy; 16 prompted by MBI alone (PPV=25%) and 2 prompted by Mammography (PPV=0%). All 5 cancers detected by MBI were also visible on the 148 MBq (4 mCi) equivalent images.
CONCLUSION: Although the study is ongoing, findings from this interim analysis indicate that low-dose, dual-head MBI can be a useful adjunct and potential alternative to screening mammography in women with dense breasts. A follow-up mammogram at one-year for this cohort and further study of incident screening MBI will be necessary to establish true sensitivity and specificity data. Ongoing dose reduction work will allow MBI screening to be performed with 74-148 MBq (2-4 mCi) Tc-99m Sestamibi, with effective dose comparable to screening mammography.
About Gamma Medica, Inc.-Clinical Division
Gamma Medica, Inc. (www.gammamedica.com) Clinical Division designs, builds and services the LumaGEM™ Molecular Breast Imaging (MBI) System. The LumaGEM™ MBI System is the first commercially available, FDA cleared, planar, dual head, fully solid state digital imaging system utilizing cadmium zinc telluride (CZT) technology used for breast imaging.
Source: Gamma Medica
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